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Vegetarian Diet in Ulcerative Colitis (LOVUC)

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ClinicalTrials.gov Identifier: NCT04018040
Recruitment Status : Recruiting
First Posted : July 12, 2019
Last Update Posted : July 12, 2019
Sponsor:
Collaborator:
St John of God Subiaco Hospital, Subiaco
Information provided by (Responsible Party):
Charlene Grosse, Edith Cowan University

Brief Summary:
To determine whether a lacto-ovo vegetarian diet is effective in improving gastrointestinal symptoms, quality-of-life, intestinal inflammation and gut microbiota composition in mild-to-moderate UC compared to a standard omnivorous diet.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Other: Lacto-ovo vegetarian diet Not Applicable

Detailed Description:
This study will review whether a lacto-ovo vegetarian diet is an optimal dietary therapy to achieve a clinical response in mild to moderate UC as an adjunctive treatment to current medical therapies. The proposed RCT will be used to evaluate the efficacy of a lacto-ovo vegetarian diet together with its effect on the microbiota to create an enhanced understanding of the role diet plays in the management of UC. Using a socially acceptable diet it is anticipated that food-related quality-of-life measures will improve for participants. Dietary modification could be a more economical, safer and more effective means of reducing symptoms and flare-ups compared to pharmacological therapy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Phase 1: Open labelled, single centre trial (10 patients) Phase 2: Open labelled, single centre, single blinded, randomised controlled clinical trial (n=30).
Masking: Single (Care Provider)
Masking Description: Due to the nature of this type of dietary intervention it is not possible to blind the participant, but the assessing doctor will be blinded to the patient's diet during phase two.
Primary Purpose: Treatment
Official Title: Efficacy of a Lacto-ovo Vegetarian Diet in Ulcerative Colitis: a Randomised Controlled Trial
Actual Study Start Date : May 6, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control Group
Patients will be asked to continue their usual diet patterns over an 8 week period
Experimental: Intervention Group
Patients will follow a lacto-ovo vegetarian diet for an 8 week period. patients will be provided with a lacto-ovo vegetarian food box delivery service with fresh ingredients and recipes to cover four dinners per week.
Other: Lacto-ovo vegetarian diet
Lacto-ovo vegetarian diet inclusive of dairy and eggs




Primary Outcome Measures :
  1. Number of participants with a clinical response at week 8 [ Time Frame: Week 8 ]
    A clinical response is defined as a decrease from baseline in the total Mayo score of at least three points, with an accompanying decrease in the subscore for rectal bleeding or at least 1 point or an absolute subscore for rectal bleeding of 0 or 1


Secondary Outcome Measures :
  1. Number of participants achieving clinical remission at week 8 [ Time Frame: Week 8 ]
    A clinical remission is defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point.

  2. Number of participants with changes to IBDQ score at week 8 [ Time Frame: Week 8 ]
    Change in total score from baselines. IBDQ - normal quality of life score is 170 points (range 32 to 224) and a quality of life response is a change of 16 points.

  3. Participants Food related quality of life in IBD (Fr-QoL 29) score at week 8 [ Time Frame: Week 8 ]
    Change in total score from baseline. Lowest score of 29 reflects poor quality of life, maximum score of 145 reflects highest quality of life score.

  4. Participants SF-36 quality of life score at week 8 [ Time Frame: Week 8 ]
    SF-36- change in total score from baseline. A score of 0 reflects maximum disability, the maximum score of 100 reflects no disability.

  5. Number of participants achieving mucosal healing at week 8 [ Time Frame: Week 8 ]
    Mucosal healing is defined as an absolute endoscopy subscore of 0 or 1(maximum score of 3).

  6. Number of participants achieving a change in gut microbiome diversity at week 8 [ Time Frame: Week 8 ]
    The gut microbiome will be examined using ITS2, 16S rRNA gene and metagenomics.

  7. Number of participants with a change in beneficial gut metabolome profile at week 8 [ Time Frame: Week 8 ]
    Untargeted metabolomics will be performed on stool samples using high-resolution Gas Chromatography Mass Spectrometry (GC-Orbitrap-MS). Metabolite identification will be established prior to statistical analysis, by matching against an in-house MS/MS spectral library of 900 metabolites and searching online spectral libraries (mzCloud, Metlin, HMDB and Massbank).



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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • I. Is able to provide informed consent. II. Is over the age of 18 years. III. Has a diagnosis of ulcerative colitis for over a 3-month duration that was confirmed by a specialist gastroenterologist with a MAYO score up to 9.

IV. Medications:

  1. Oral 5-Aminosalicylates: If taking an oral 5-Aminosalicylates the patient has used them continuously for 4 weeks and has been on a stable dose for 2 weeks prior to the screening visit.
  2. Oral Corticosteroids: If taking oral corticosteroids the patient has used them continuously for 4 weeks and has been on a stable dose for 2 weeks prior to the screening visit at a dose of ≤30mg.
  3. Oral Azathioprine/6MP, Methotrexate or tacrolimus: If taking one of these medications the patient has used them for a minimum of 12 weeks and has been on a stable dose for 4 weeks prior to screening.
  4. Biologic therapy with infliximab, adalimumab or vedolizumab: If taking one of these medications the patient has used them for a minimum of 12 weeks
  5. Rectal Preparations; 5-Aminosalicylates, corticosteroids or tacrolimus: If taking one of these medications the patient has used them continuously for 4 weeks and has been on a stable dose for 2 weeks prior to the screening visit.

V. Willing to participate in the study and comply with the proceedings by signing a written informed consent.

VI. Free of any clinically significant disease, other than ulcerative colitis, that would interfere with the study's evaluations.

VII. Subjects can read and understand English and is able to adhere to the study methodology and visit schedules.

Exclusion Criteria:

  • I. Has Crohn's disease. II. Has been on antibiotics within the last four weeks. III. Has a known food allergy to nuts, soy, eggs or dairy. IV. Is pregnant or breast feeding. V. Following a vegetarian, vegan or low FODMAP diet. VI. Has known dementia and the inability to understand the trial requirements.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04018040


Contacts
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Contact: Charlene Grosse 0893826070 Cgrosse0@our.ecu.edu.au
Contact: Claus Christophersen 0863045278 c.christophersen@ecu.edu.au

Locations
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Australia, Western Australia
St John of God Subiaco Hospital Recruiting
Perth, Western Australia, Australia, 6111
Contact: Charlene Grosse    0893826070    Cgrosse@our.ecu.edu.au   
Sub-Investigator: Ian Lawrance         
Sub-Investigator: Claus Christopherson         
Sub-Investigator: Amanda Devine         
Sub-Investigator: Johnny Lo         
Sponsors and Collaborators
Edith Cowan University
St John of God Subiaco Hospital, Subiaco
  Study Documents (Full-Text)

Documents provided by Charlene Grosse, Edith Cowan University:

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Responsible Party: Charlene Grosse, Advanced Accredited Practising Dietitian, PhD Candidate, Edith Cowan University
ClinicalTrials.gov Identifier: NCT04018040     History of Changes
Other Study ID Numbers: EdithCowanU
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All data will be de-identified

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases